Periodontitis Clinical Trials

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Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Periodontitis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Periodontitis is a chronic, irreversible inflammatory disease affecting the supporting structures of the teeth. It is most commonly caused by bacteria in dental plaque, also known as biofilm. The disease typically begins as gingivitis, a reversible inflammation of the gums resulting from plaque accumulation. Without appropriate intervention-such as maintaining proper oral hygiene and removing plaque-gingivitis can progress to periodontitis, leading to the loss of clinical attachment, alveolar bone resorption, and eventually tooth loss. Early diagnosis and regular treatment of periodontal disease are essential to prevent disease progression. The treatment of periodontitis is primarily causal and involves the mechanical removal of plaque. Initial therapy is non-surgical, consisting of scaling and root planing, and may be followed by surgical procedures if required. In addition to mechanical cleaning, increasing attention has been given to adjunctive, non-invasive therapies such as mouth rinses or oral solutions containing chlorhexidine or hydrogen peroxide. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Hydrogen peroxide mouth rinses have been used for more than a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. However, despite their long history of use, clinical studies evaluating hydrogen peroxide-based mouth rinses remain limited and heterogeneous in design, which makes it difficult to compare findings across studies. The objective of this post-marketing clinical study is to generate additional data on the safety and efficacy of a hydrogen peroxide mouth rinse as an adjunctive therapy in the treatment of periodontitis. The study will evaluate two hydrogen peroxide concentrations: a 1.5% solution (Oroxid® sensitive) and a 3% solution (Oroxid® forte).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Systemically healthy participants aged 18 years or older.

• Generalized periodontitis, Stage III, Grade B.

• Presence of three or more periodontal pockets deeper than 5 mm.

• At least 16 natural teeth (excluding wisdom teeth).

• Ability to comply with oral hygiene instructions following the intervention.

• Signed informed consent form after being fully informed about the study.

Locations
Other Locations
Slovenia
Klinika Križaj Ljubljana
RECRUITING
Ljubljana
Ustna medicina d.o.o.
RECRUITING
Ljubljana
Contact Information
Primary
Dominika Tompa Majcen, MPharm
dominika@enikam-oxy.com
+386 40 530 663
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 90
Treatments
Experimental: OROXID® forte oral solution
Medical device: OROXID® forte oral solution
Experimental: OROXID® sensitive oral solution
Medical device: OROXID® sensitive oral solution
Other: Standard of Care
Oral solutions are not allowed
Related Therapeutic Areas
Sponsors
Leads: ENIKAM d.o.o.

This content was sourced from clinicaltrials.gov